BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7975010 · Received October 17, 2018

    Report

    Report Number
    9610048-2018-00169
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 6, 2018
    Report Date
    December 5, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE UNIT BELONGING TO LOT NUMBER 8002803 AND ONE PICTURE SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON VISUAL INSPECTION OF THE SAMPLES, THE NEEDLE WAS OBSERVED PARTIALLY RETRACTED WHICH INDICATED THAT INTERNAL DAMAGE PREVENTED THE SAFETY MECHANISM FROM MOVING COMPLETELY. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. IT HAS BEEN DETERMINED THAT THE DEFECT OCCURRED WITHIN THE ASSEMBLY MACHINE DUE TO AN EQUIPMENT DEFECT. THE ASSEMBLY STATION SOFTWARE HAS BEEN UPDATED TO DETECT DEFECTS OF THIS KIND. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHIELDED IV CATHETER EXHIBITED NEEDLE RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXHIBITED NEEDLE RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817045 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVENOUS CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8002803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other